Law Commons^™

An Information Prescription For Prescription Drug Regulation, Anita Bernstein, Joseph Bernstein

Faculty Scholarship

No abstract provided.

Contemporary Water Issues, Susan Kelly

Publications

No abstract provided.

Punishing Pharmaceutical Companies For Unlawful Promotion Of Approved Drugs: Why The False Claims Act Is The Wrong Rx, Vicki W. Girard

Georgetown Law Faculty Publications and Other Works

This article criticizes the shift in focus from correction and compliance to punishment of pharmaceutical companies allegedly violating the Food, Drug, & Cosmetic Act (FD&C Act) prohibitions on unlawful drug promotion. Traditionally, the Food and Drug Administration (FDA) has addressed unlawful promotional activities under the misbranding and new drug provisions of the FD&C Act. Recently though, the Justice Department (DOJ) has expanded the purview of the False Claims Act to include the same allegedly unlawful behavior on the theory that unlawful promotion “induces” physicians to prescribe drugs that result in the filing of false claims for reimbursement. Unchecked and unchallenged, …

Land & Water Planning: Another State's Perspective - Water Resources Regional Plan Policies, Kathleen M. Chavez, P.E.

Publications

No abstract provided.

Constitutional Flaw?, Carl E. Schneider

Articles

Do terminally ill patients have a constitutional right "to decide, without FDA interference, whether to assume the risks of using potentially life-saving investigational drugs that the FDA has yet to approve for commercial marketing, but that the FDA has determined, after Phase I clinical human trials, are safe enough for further testing"? In Abigail Alliance for Better Access to Developmental Drugs v. McClellan, the United States District Court for the District of Columbia said "no." In Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, a panel (three judges) of the United States Court of Appeals …

Wyeth V. Levine And Its Implications, Brian Wolfman

Georgetown Law Faculty Publications and Other Works

The U.S. Supreme Court’s decision in Wyeth v. Levine sharply limited the availability of implied preemption as a defense in pharmaceutical cases. In this Analysis & Perspective, attorney Brian Wolfman discusses the decision and its implications for prescription drug litigation as well as litigation in other areas that are regulated by the federal government.

After Wyeth, Wolfman says, a defendant in a prescription drug case must demonstrate a ‘‘tight fit between the labeling change proposed by the manufacturer (and rejected by the FDA) and the labeling change that the plaintiff contends would have prevented her injuries.’’ Moreover, he says, …

Steps To Flow Restoration: Lessons From The Northwest, Reed D. Benson

Publications

No abstract provided.

Ecological Flows In New Mexico - It Has Been Done, Adrian Oglesby

Publications

No abstract provided.

The Pragmatics Of Allocating Water For Stream Flows, Steve Harris

Publications

No abstract provided.

New Mexico Wildlife Conservation Act: Cooperative Action For Native Species Recovery, Stephanie Carman, David Propst

Publications

No abstract provided.

Cloned Meat, Voluntary Food Labeling, And Organic Oreos, Donna M. Byrne

Faculty Scholarship

In December 2006, the Food and Drug Administration (FDA) announced that it had reviewed all the available evidence and was poised to approve meat and milk from cloned animals and their progeny. Such products, said the FDA, are virtually identical to meat or milk from a non-clone. Further, the FDA announced it would almost certainly not require food from clones to be labeled as such. Part I of this article identifies three functions that labels perform, outlines the types of information usually required, and introduces the rule that voluntary label information cannot be misleading. Part II focuses on process information …

Kidney Transplantation: Only For The Well-To-Do?, Jennifer M. Smith

Journal Publications

The world of organ transplantation remains a wealthy one, especially in the United States. This is especially true for kidney transplantations, which involve the solid organ most in demand. Increasingly, transplant professionals desperately push for more solutions to overcome the organ transplant shortage that exists in the United States. Congress has introduced legislation that addresses the additional problem of the high cost of post-transplant anti-rejection medications by providing that the government will pay eighty percent of the cost for the post-transplant medications for life. But unless this bill passes and other needed changes are made, kidney transplantation remains an option …

Revisiting The Regulation Debate: The Effect Of Food Marketing On Childhood Obesity, Nicole E. Negowetti

Law Faculty Publications

No abstract provided.

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Journal Articles

This Commentary is part of a colloquy on race-based genetics research.

Marketing Mothers' Milk: The Commodification Of Breastfeeding And The New Markets For Breast Milk And Infant Formula, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

This paper explores the commodification of women and biological processes, the confusion of scientific evidence with social agendas, and the conflict between marketing and public health. I assert that key actors in the healthcare marketplace - government, businesses, and doctors – have acted to enable weak medical and scientific evidence to be manipulated by ideological and profit-making partisans in a poorly regulated market. I focus on the unique role of the medical profession, which has acted with government and the private sector to shape the markets in human milk and infant formula. In a striking parallel to the pharmaceutical industry, …

A New History And Discussion Of 180-Day Exclusivity, Erika Lietzan, David E. Korn, Shaw W. Scott

Faculty Publications

This is the third in a series of articles on 180-day exclusivity. The first article traced the history of 180-day exclusivity from 1984 through its amendment in 2003 and court cases in 2004. A second article, published by two of the authors in 2007, updated the earlier piece through the end of 2006 but was arranged by issue rather than in a chronology. This article, which includes a third author, provides a comprehensive resource on 180-day exclusivity for old abbreviated new drug applications (ANDAs) (but less detail in some places where the 2007 article may be referenced) and focuses more …

Reconceptualizing Human Rights To Challenge Tobacco, Rangita De Silva De Alwis, Richard Daynard

All Faculty Scholarship

No abstract provided.

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Journal Articles

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

An Economic Justification For Open Access To Essential Medicine Patents In Developing Countries, Sean Flynn, Aidan Hollis, Mike Palmedo

Articles in Law Reviews & Other Academic Journals

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the “deadweight losses” caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which …

On The Limits Of Supremacy: Medical Marijuana And The States' Overlooked Power To Legalize Federal Crime, Robert A. Mikos

Vanderbilt Law School Faculty Publications

Using the conflict over medical marijuana as a timely case study, this Article explores the overlooked and underappreciated power of states to legalize conduct Congress bans. Though Congress has banned marijuana outright, and though that ban has survived constitutional scrutiny, state laws legalizing medical use of marijuana constitute the de facto governing law in thirteen states. This Article argues that these state laws and (most) related regulations have not been, and, more interestingly, cannot be preempted by Congress, given constraints imposed on Congress's preemption power by the anti-commandeering rule, properly understood. Just as importantly, these state laws matter, in a …

Demythologizing Phosita: Applying The Non-Obviousness Requirement Under Canadian Patent Law To Keep Knowledge In The Public Domain & Foster Innovation, Matthew Herder

Articles, Book Chapters, & Popular Press

The Supreme Court of Canada recently revised the doctrine of non-obviousness in a pharmaceutical “selection patent” case, Apotex Inc. v. Sanofi-Synthelabo Canada Inc. Although cognizant of changes to the same doctrine in the United States and the United Kingdom, a critical flaw in how the doctrine is being applied in Canada escaped the Court’s attention. Using content analysis methodology, this article shows that Canadian courts frequently fail to characterize the “person having ordinary skill in the art” (PHOSITA) for the purpose of the obviousness inquiry. The article argues that this surprisingly common analytical mistake betrays a deep misunderstanding of innovation, …

Regulatory Dysfunction: How Insufficient Resources, Outdated Laws, And Political Interference Cripple The 'Protector Agencies', Sidney A. Shapiro, Rena I. Steinzor, Matthew Shudtz

Faculty Scholarship

In the last several years, dramatic failures of the nation’s food safety system have sickened or killed tens of thousands of Americans, and caused billions of dollars of damages for producers and distributors of everything from fresh vegetables to granola bars and hamburger meat. In each case, the outbreak of food-borne illness triggered what can only be described as a frantic scramble by health officials to discover its source. Inevitably, the wrong lead is followed or a recall is too late or too narrow to prevent further illnesses, and the government has to defend itself against withering criticism. Americans expect …

Crises, Congress, And Cognitive Biases: A Critical Examination Of Food And Drug Legislation In The United States, Sharon B. Jacobs

Publications

No abstract provided.

Making Sense Of Drug Regulation: A Theory Of Law For Drug Control Policy , Kimani Paul-Emile

Faculty Scholarship

This article advances a new theory of drug regulation that addresses two previously unexamined questions: how law-makers are able to regulate drugs differently irrespective of the dangers the drugs may pose and independent of their health effects, and the process followed to achieve this phenomenon. For example, although tobacco products are the leading cause of preventable death in the U.S. they can be bought and sold legally by adults, while marijuana, a substantially safer drug, is subject to the highest level of drug control. This article posits a conceptual model for making sense of this dissonance and applies this model …

Dying To Know: A Demand For Genuine Public Access To Clinical Trial Results Data, Christine Galbraith Davik

Faculty Publications

Four years ago at the age of 34, I heard the awful words "I'm sorry, but you have breast cancer" coming from my doctor. After the initial shock of the diagnosis wore off, I like many others who have faced life-threatening diseases began to work with a team of physicians to develop an appropriate treatment plan, which included contemplating enrollment in a clinical trial. Quite unexpectedly, my position as an intellectual property professor whose scholarship focuses primarily on information control, my role as a member of my university's Institutional Review Board that oversees studies involving human subjects, and my newly …

Consumer Protection In An Era Of Globalization, Cary Coglianese, Adam M. Finkel, David T. Zaring

All Faculty Scholarship

With expanding global trade, the challenge of protecting consumers from unsafe food, pharmaceuticals, and consumer products has grown increasingly salient, necessitating the development of new policy ideas and analysis. This chapter introduces the book, Import Safety: Regulatory Governance in the Global Economy, a multidisciplinary project analyzing import safety problems and an array of innovative solutions to these problems. The challenge of protecting the public from unsafe imports arises from the sheer volume of global trade as well as the complexity of products being traded and the vast number of inputs each product contains. It is further compounded by the …

Owning What You Eat: The Discourse Of Food, David N. Cassuto

Elisabeth Haub School of Law Faculty Publications

This essay examines the role of communication in the formation of law and social norms and the implications of that role for animal law and ethics. Part III contextualizes animal law within contemporary risk society. Part IV looks at how efficiency has transformed from an economic concept into a normative guideline and discusses how that transformation has affected animals and agriculture. It tracks the rise of industrial agriculture and ties it to this fundamental misunderstanding of the concept of efficiency. The essay concludes with some thoughts on how to reformulate contemporary notions of efficiency and ethics to account for the …

Rethinking The Role Of Clinical Trial Data In International Intellectual Property Law: The Case For A Public Goods Approach, Jerome H. Reichman

Faculty Scholarship

This article is a later version of the author's presentation at the Eleventh Annual Honorable Helen Wilson Nies Memorial Lecture March 26, 2008. Clinical trials are currently used to test drugs; however, the risk and cost of clinical trials are increasing so drastically that the clinical trials may become unsustainable. This article evaluates the legal and economic trends of intellectual property protection for pharmaceutical clinical trial data. The protection of clinical trials has become an alternative to patents as market exclusivity encourages the development and testing of unpatentable pharmaceuticals. This author argues that clinical trials should be treated as a …

Compulsory Licensing Of Patented Pharmaceutical Inventions: Evaluating The Options, Jerome H. Reichman

Faculty Scholarship

In this Comment, the author traces the relevant legislative history pertaining to compulsory licensing of patented pharmaceuticals from the TRIPS Agreement of 1994 to the 2003 waiver to, and later proposed amendment of, article 31, which enables poor countries to obtain needed medicines from other countries that possess manufacturing capacity. The Comment then evaluates recent, controversial uses of the relevant legislative machinery as viewed from different critical perspectives. The Comment shows how developing countries seeking access to esential medicines can collaborate in ways that would avoid undermining incentives to innovation and other social costs attributed to compulsory licensing. It ends …

The Public’S Right To Health: When Patient Rights Threaten The Commons, Elizabeth Weeks Leonard

Scholarly Works

This Article offers a contemporary examination of traditional public health objectives to address social problems not amenable to individual resolution. Taking the tradition a step further, it defines a "public health right" that may justify certain government actions that otherwise appear to impair individual rights. For example, lawmakers are considering whether current regulations on prescription drugs should be loosened to allow terminally ill patients to access drugs before they have been tested and approved for the general public. This Article concludes that expanding access to experimental drugs would violate the public health right to scientific knowledge and new drug development. …